Merck to seek approval for two cardiovascular drugs in '13

August 26, 2012|Reuters

(Jeff Zelevansky, REUTERS)

(Reuters) - Merck & Co said on Sunday it plans to file regulatory applications for a new type of blood clot preventer next year, and will also file with regulators for approval of another cardiovascular drug in 2013.

The pharmaceutical company said in a statement that it is in discussions with regulatory agencies over vorapaxar, a drug that has been dogged by bleeding concerns since January 2011, when a safety committee overseeing a large study said the new type of anti-platelet drug was not appropriate for patients who had suffered a stroke.

It plans to file the application with regulators in the United States and Europe in 2013.

Merck said it will "seek an indication for the prevention of cardiovascular events in patients with a history of heart attack" and no history of stroke.

Merck obtained vorapaxar through its $41 billion acquisition of rival Schering Plough in late 2009. At the time, it was considered to be the crown jewel of Schering Plough's drug pipeline.

Regarding a cardiovascular drug called MK-524A (tredaptive), Merck said its study is on track to be completed later this year and it plans to file for approval in the United States and the EU in 2013.

Merck said studies for anacetrapib are also on track to be completed in 2017. Oxford researchers, which are leading the study, have already enrolled 20,000 patients, in what is one of the largest cardiovascular studies ever conducted. The study started in 2011.